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Roots Analysis - The Human Microbiome Market: Focus on Therapeutics

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Crescendo Global

Roots Analysis Report - Overview

The human body is known to harbor numerous communities of microbes, including both beneficial and harmful species, which are collectively referred to as the microbiota. Likewise, the ecological system of commensal, symbiotic, and perhaps pathogenic microorganisms that reside within a host system is called the microbiome.  Research insights, generated primarily  from the Human Microbiome Project (2009) and other independent studies, have demonstrated that an imbalance in the microbiome (also known as dysbiosis) may lead to the development of several chronic clinical conditions, including Clostridium difficile infections (CDIs), irritable bowel syndrome (IBS), diabetes, Crohn’s disease and ulcerative colitis.  Given the role of the microbiota in both disease development and pathogenesis, the concept of microbiome-based therapeutics has generated significant enthusiasm within the medical science community, defining a new frontier in the field of medicine. The growing popularity and interest in the therapeutic potential of the microbiome is evident across scientific literature; commonly cited terms in this context include microbiome, microflora, microbiota, fecal microbiota therapy (FMT), microbiome diagnostics, or human microbiome, as observed on the NCBI’s PubMed portal, over the last three years. 

Scope of the Report

‘The Human Microbiome Market: Focus on Therapeutics (including gut-brain axis targeting drugs), Diagnostics and Fecal Microbiota Therapies (3rd Edition), 2019-2030’ report features an extensive study of the current market landscape, offering an informed opinion on the likely adoption of microbiome-based medical products (including therapeutics, diagnostics and FMTs), over the next decade. The report features an in-depth analysis, highlighting the diverse capabilities of stakeholders engaged in this domain. In addition to other elements, the study includes:

  • A detailed assessment of the current market landscape of microbiome therapeutics, providing information on drug / therapy developer(s) (such as year of establishment, location of headquarters and company size), clinical study sponsor(s) or collaborators, phase of development (clinical, preclinical, and discovery stage) of product candidates, type of molecule (small molecule and biologic), type of therapy (prebiotic, probiotic, and prescription drug), target indication(s), key therapeutic area(s), molecular / biological target (if available), mechanism of action (if available), route of administration, type of drug formulation (tablet, capsule, gel, lotion, cream, ointment, nasal spray and 4+ categories), dosing frequency (reported for clinical candidates only), and information on special drug designations (if any). In addition, the chapter highlights the various technology platforms that are being actively used for the development of microbiome therapeutics.
    • Elaborate profiles of key players (established after 2005) that are engaged in the development of microbiome therapeutics (which are presently in both preclinical and clinical stages of development); each profile features a brief overview of the company, its financial information (if available), microbiome-based product portfolio, information on advanced stage (phase II and above) pipeline candidates (featuring a drug overview, current status of development, clinical trial information, and clinical trial end-point analysis) and an informed future outlook. 
    • A discussion on the various types of diagnostic tests, specifically highlighting the importance of next-generation sequencing within this field of research, along with [A] a detailed review of the current market landscape of microbiome diagnostic tests, including the information on the developer(s) (such as year of establishment, location of headquarters and company size), stage of development (commercialized and under development), type of sample used (blood, feces, saliva and vaginal swab), target indication(s), key therapeutic area(s), result turnaround time, and purpose of diagnosis, [B] brief profiles of popular diagnostic developers, and [C] an indicative list of screening and profiling test kits, including information on the developer(s) (such as year of establishment, location of headquarters and company size), type of sample used (blood, feces, saliva and vaginal swab), key therapeutic area(s), and result turnaround time.
  • Contents

    Chapter Outlines

    Chapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the current state and likely evolution of microbiome therapeutics, diagnostics and FMT therapies market in the short-mid term and long term.

    Chapter 3 is an introductory chapter that highlights important concepts related to the human microbiome, including a discussion on the role of resident microorganisms in disease development (particularly for conditions caused by an imbalance in the microbiome) and in certain cases, prevention. It presents an elaborate discussion on various functions of the microbiota, emphasizing on the key aspects of the Human Microbiome Project (HMP). Further, the chapter describes the various types of microbiome therapeutics, such as probiotics and prebiotic drugs, which are available / under development. It also provides an overview of the regulatory requirements for live biotherapeutic products (LBPs), in addition to highlighting the challenges associated with the development of microbiome therapeutics.

    Chapter 4 includes information on 260 microbiome therapeutics that are currently being evaluated in different stages of development (both clinical and preclinical / discovery). It features a comprehensive analysis of pipeline molecules based on their phases of development (clinical, preclinical, and discovery stage), type of molecule (small molecule and biologic), type of therapy (prebiotic, probiotic, and prescription drug), target indication(s), key therapeutic area(s), molecular / biological target (if available), mechanism of action (if available), route of administration, type of drug formulation (tablet, capsule, gel, lotion, cream, ointment, nasal spray and 4+ categories), dosing frequency (reported for clinical candidates only), and information on special drug designation (if any). Further, the chapter provides information on drug developer(s), highlighting their year of establishment, location of headquarters and company size. It also highlights the various microbiome therapeutics that have been discontinued over the last few years. In addition, the chapter highlights the various technology platforms that are being actively used for the development of microbiome therapeutics.

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